Abstract & Summary

A Study of Laparoscopic Surgical Anatomy of Infraumbilical Posterior Rectus Sheath, Fascia Transversalis & Pre-Peritoneal Fat/ Fascia during TEPP Mesh Hernioplasty for Inguinal Hernia

A Thesis Submitted for the award of the Degree of DOCTOR OF PHILOSOPHY In SURGERY By DR. MAULANA MOHAMMED ANSARI MBBS, MS (Surgery) Department of Surgery Faculty of Medicine, Jawaharlal Nehru Medical College Aligarh Muslim University, Aligarh, UP, INDIA – 202001

May, 2016

Abstract & Summary

M.M. Ansari

PhD Thesis (Surgery)

Abstract

ABSTRACT Background: Contrary to the general belief, extraperitoneal anatomy of the groin is reported to be complex, and is often not properly understood by majority of the practicing surgeons, leading to difficulties in performing the laparoscopic preperitoneal repair of the inguinal hernia, especially in presence of the anatomic variations reported by several investigators over the last several decades, which have received little/no attention of the anatomists & the practicing surgeons alike. Most studies are based on the gross anatomic dissections. Studies on the live surgical anatomy during laparoscopic hernioplasty are scarce and sparsely reported in the literature and hence the present study. Objective and Aims: To perform the laparoscopic total extra-peritoneal preperitoneal hernioplasty (TEPP) for inguinal hernia and to study the morphology of the posterior rectus sheath, arcuate line, pre-peritoneal fat/fascia and transversalis fascia below umbilicus during the TEPP hernioplasty. Research Methodology: After approval, TEPP hernioplasty was performed under the written informed consent of the patient (Fig. 1). The standard 3-midline-port technique was adopted, utilizing direct telescopic dissection in most of the cases under CO2 insufflation pressure of 12 mmHg. Instant data collection and documentation were done along with video recording as and when digital video recorder was available. Patients were followed for a period of 5 to 61 months after discharge from the hospital. Statistical analysis was carried out, utilizing the SPSS software (v. 21) mainly. Results: A total of 63 patients with uncomplicated primary inguinal hernia (unilateral 54; bilateral 9) were taken up for TEPP hernioplasty. Three patients required early conversion and were excluded from the study. The remaining 60 patients underwent TEPP hernioplasty successfully for 52 unilateral hernias (left side 35; right side 17) and 8 bilateral hernias, and thus, the data analyses were carried for a total of 68 TEPP hernioplasties (Unilateral TEPP 52; Simultaneous Bilateral TEPP 5; Interval Bilateral TEPP 3) which formed the body of the present study. The results are herein presented in the format of mean ± standard deviation unless specified otherwise.

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All patients were male, with an overall mean age and BMI of 50.1±17.2 years (range 18-80) and. 22.6±2.0 kg/m2 (range 19.3-31.2) respectively. The ratio of ASA grades I and II was 4.5: 1. Variations were observed in all the primary outcome measures of the anatomic structures in a high percentage of the cases. A total of 12 morphological types of posterior rectus sheath were observed, with classical anatomy in 46% of cases and variant anatomy in the remaining 54%. Non-mirror anatomy of the PRS was observed on the two sides of the body in 75% of the bilateral hernias. A total of 7 morphological types of arcuate line (inferior border of posterior rectus sheath) were recorded, with classical arcuate line in 46% of the cases and variant arcuate line in the remaining 54%. Non-mirror anatomy of the AL was observed on the two sides of the body in 62.5% of the bilateral hernias. In the suprainguinal region, the transversalis fascia was found as a well-defined single membranous layer (72%) and thinned-out flimsy layer (28%). However, in the inguinal region, transversalis fascia was of three types – single diaphanous layer (60%), single membranous layer (15%) and thinned-out flimsy layer (25%). Preperitoneal fascia was observed in all cases - as a definite single membranous layer in 82% of the cases, and as a double membranous layer in the remaining 18%. Preperitoneal fat in the present study was minimally fatty in 56%, moderately fatty in 34%, and excessively fatty in 10% of the cases. The anatomy of the transversalis fascia, preperitoneal fascia and preperitoneal fat was a mirror image on the two sides of the body in all cases of bilateral hernias. Wide variations were also recorded in the different analogs of these anatomic structures. The variant anatomy of the posterior rectus sheath, arcuate line, transversalis fascia and preperitoneal fascia adversely affected the secondary outcome measures of endoscopic vision, ease of procedure, operation time, peritoneal injury and surgical emphysema. However, the postoperative seroma, infection and chronic pain were not affected by the presence of the anatomic variations. Conversion secondary to anatomic variation was seen in 1.6% of the cases. Variations in the preperitoneal fat did not affect any of the secondary outcome measures. There was no recurrence of hernia in the mean follow up period of 33 ± sd 17 months (range 5-61 months).

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A well-defined ‘rectusial fascia’ was also seen consistently in all patients, which represented the fascial condensation and thickening in the epimysium of the rectus abdominis muscle, along with a ‘retropubic fascia’ as its extension analog. Internal spermatic fascia was found consistently as an extension analog of the preperitoneal fascia in all cases, along with a secondary internal inguinal ring. Cord Lipoma was present in 16% of the cases and was observed as an extension analog of the preperitoneal fat. In a nut shell, incidence of the individual variant anatomy in the 4 major structures studied, namely, posterior rectus sheath, arcuate line, transversalis fascia and preperitoneal fat/fascia ranged from 18% to 54% of the cases, along with a high percentage of overlap. Individual anatomic variations in the transversalis fascial analogs and the rectusial fascia varied from 7% to 84% of the cases. Thus overall incidence of the anatomic variations singly or in combination was 76.5% with respect to the 4 structures of primary outcome measure only, and 100% with respect to all the structures studied in the present work. The present observations confirmed that the total extraperitoneal preperitoneal (TEPP) approach for inguinal hernioplasty with the unhurried telescopic dissection provided an excellent perspective and opportunity not available with any other technique including the TAPP (transabdominal preperitoneal hernioplasty), and helped us in improving our accurate understanding of the abdomino-pelvic anatomy. As the seeing was the believing, the present study instilled a high degree of confidence in the surgical residents and peer colleagues to adopt the TEPP hernioplasty in order to exploit its proven advantages and benefits and to improve the quality patient care. Conclusions: The preperitoneal anatomy of the infra-umbilical and inguinal regions showed wide variations in the all the fascial layers studied, with significant impact on the intra-operative working as well as the post-operative clinical outcomes, indicating the paramount importance of their timely recognition and judicious surgical dissection of the complex fascial tissue planes of the groin in order to perform the TEPP hernioplasty with ease, rapidity and safety for the lasting cure and greatest patient satisfaction. Incidence of the individual variant anatomy in the 4 major structures studied, namely, posterior rectus sheath, arcuate line, transversalis fascia and preperitoneal fat/fascia ranged from 18% to 54% of the cases, along with a high percentage of overlap. Individual anatomic variations in the transversalis fascial analogs and the rectusial fascia 4

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Abstract

varied from 7% to 84% of the cases. Thus the overall incidence of the anatomic variations singly or in combination was found 76.5% with respect to the 4 structures of primary outcome measure only, and 100% with respect to all the structures studied in the present work. The present study also discovered the presence of a double-layer preperitoneal fascia, internal spermatic fascia as an extension analog of the preperitoneal fascia, cord lipoma as an extension analog of the preperitoneal fat and a new structure of ‘rectusial fascia’ with the ‘retropubic fascia’ as its extension analog. In this area, there is a tremendous scope for future research with the use of newer laparoscopic approaches. More laparoscopic studies may help us in further stratification and easy understanding of the anatomic entities in order to eradicate the erroneous descriptions and interpretations from the literature. Utilization of pre-operative high definition ultrasonography, intra-operative high definition endovision, and modern energy sources like Harmonic scalpel/LigaSure for surgical dissection will prove a boon to enhance the precise knowledge of the preperitoneal anatomy among the practicing surgeons for the betterment of the quality patient care for the masses. Use of a virtual-reality digital learning and training programme for the surgical anatomy for the TEPP hernioplasty will be a worthy pursuit, strategic investment and rewarding exercise to materialize the fast-evolving concept of ‘Digital Surgical Skill Lab’ under a scientific anatomic model as the one proposed in the thesis.

--- End of Abstract ---

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Figure 1: Present Study at a Glance

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Abstract

SUMMARY OF THESIS Layout 1) 2) 3) 4) 5) 6) 7) 8)

Introduction Aims & Objectives Historical Background & Contemporary Issues Research Methodology Outcome Measures in the Present Study Observations & Results Discussion Conclusions

1. Introduction The traditional oversimplified description of the inguinal anatomy is still taught in our anatomy classrooms leading to a fixed mindset that often proves counterproductive for instant recognition and precise dissection of the anatomical structures required during the laparoscopic surgery, especially by the upcoming young surgeons. Contrary to the general belief, extraperitoneal anatomy of the groin is reported to be complex (Arregui, 1997; Lange, et al, 2002), and is not properly understood by the majority of the practicing surgeons (Arregui, 1997; Colborn and Skandalakis, 1998; Lange et al, 2002; Faure et al; 2006), leading to difficulties in performing the laparoscopic preperitoneal repair of the inguinal hernia, with a long learning curve (Faure et al, 2006; Liem et al, 1996), as well as its lack of popularity among our surgical community despite the obvious advantages and better results (Lange et al, 2002). Inadequate understanding & improper dissection of the pre-peritoneal anatomy is now regarded as the main cause of difficulties during TEPP hernioplasty, especially in presence of the wide anatomic variations reported from time to time over the last several decades (Rizk 1980; Monkhouse and Khalique, 1986; Rizk 1991; Mwachaka et al, 2009 and 2010), which received little/no attention of the anatomists & the practicing surgeons alike. Therefore, research in the live surgical anatomy of the preperitoneal tissues of the inguinal area cannot be overemphasized for the acute need of its sound understanding warranted for smooth safe execution of the laparoscopic total extra-peritoneal pre-peritoneal (TEPP) repair of the inguinal hernia. The present study of the live surgical anatomy during the excellent perspective, lighting and magnification of laparoscopy was designed and conducted to address the controversies in the anatomic variations and 7

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their interpretations regarding the different preperitoneal layers of the inguinal and supra-inguinal regions and to develop a clear understanding of the anatomy of groin and its adjacent areas so as to create an easy surgical road-map towards the straightforward laparoscopic hernioplasty for the inguinal hernia.

2. Objectives and Aims The objectives and aims of the present research were to perform the laparoscopic total extra-peritoneal preperitoneal hernioplasty (TEPP) for inguinal hernia and to study the morphology of the four major structures below umbilicus during the TEPP hernioplasty, namely, (1) posterior rectus sheath (2) arcuate line of Douglas, (3) pre-peritoneal fat/fascia, and (4) transversalis fascia.

3. Historical Background and Contemporary Issues Inguinal region of the human anatomy has long been recognized as a difficult area of study, possibly secondary to its four dimensions of anatomy which varies askew from the midline to the lateral side and from the anterior to the posterior or vice versa (Bendavid, 2013). Furthermore, relationships of the structures near the internal inguinal ring are not generally known (Brick et al, 1995). Inguinal anatomy is traditionally considered in the erect position so that the transversalis fascia forms the posterior wall of the inguinal canal even in the supine position as well. There are a lot of confusions and disagreements regarding the definition and morphology of the transversalis fascia and the preperitoneal fascia (Bendavid, 2013). The problem arose when Sir Astley Cooper, the famous English surgeon and anatomist, called the transversus muscle as the transversalis muscle, and the inferior continuation of the transversus muscle was labeled as the transversalis aponeurosis or transversalis fascia, although it should have been called the transversus aponeurosis or transversus fascia that also contributes to the posterior wall of the inguinal canal (Bendavid, 2013). Annibali et al (1995) observed that the proper preperitoneal space for dissection and mesh placement lies between the two layers of the ‘preperitoneal fascia complex’, i.e. between its dorsal component, also known as the preperitoneal fascia, and its ventral component, also known as the posterior lamina of the transversalis fascia. They also made a reference to the ‘rectus abdominis fascia’ of Anson and

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McVay, and its median part, the ‘umbilico-(pre)vesical fascia’ (Anson and McVay, 1971; Arregui et al, 1994). Pierpont et al (1969) described the transversalis fascia as a separate fascial sheet as well as a part of the transversus abdominis muscle based on their observations during a large series of 1200 hernioplasties and also the gross anatomic dissections. Arregui (1997) suggested the possibility that “the posterior lamina of the transversalis fascia is made of the attenuated layers of the posterior rectus sheath”, although he also documented conclusively in the same study that “The preperitoneal fascias are distinct from the transversalis fascia (proper) with a separate blood supply” (Arregui, 1997). Moreover, he mentioned another hitherto-unknown term ‘the rectus sheath fascia’ to which the transversalis fascia, he opined, is likely related. While commenting on the article by Li et al (2012), Petros Mirilas, the noted surgeon-anatomist of Georgia, categorically declared that the concept of the ‘bilaminar’ fascia transversalis is outdated (Mirilas, 2012), based on his own exhaustive work reported earlier (Mirilas et al, 2008). Bendavid (2013) observed that “The true transversalis fascia is in fact the endoabdominal fascia which is continuous with the endopelvic fascia and the rest of the abdominal cavity. It is very thin layer, marked by a profuse cellularity which differentiates it from the aponeurotic sparse cellularity of the extensions infero-laterally of the transversus abdominis and internal oblique muscles. These last two fascial layers form the true posterior wall of the inguinal canal.” Colborn and Skandalakis (1998) observed that “The multilaminar nature of the fascia iliaca [Nobel, 1980] offers excellent concealment for the various nerves that cross the iliac fossa to pass deep to, or through, the iliopubic tract. It is clear that anatomical and surgical atlases and texts overly simplify the anatomy of the nerves in the inguinal region, and do not provide the surgeon adequate guidance in recognizing the potential hazards in the triangle of pain." Despite the emerging consensus regarding the concepts of the preperitoneal fascia and the unilaminar transversalis fascia based on the observations during the preperitoneal laparoscopy, the latest edition ( 10th) of the Schwartz’s Principles of Surgery continue to describe the so-called posterior lamina of the transversalis fascia (Wagner et al, 2015). However, the latest edition (41st) the Gray’s Anatomy unfortunately did not mention any of the two terms or structures – the preperitoneal fascia and the posterior lamina of the transversalis fascia (Rosen et al, 2016), thus keeping the controversy alive in a covert kind of manner. 9

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In a nutshell, multilaminar fascial structures are clearly seen during the preperitoneal laparoscopy but their interpretations still differ greatly among the various contemporary investigators and the practicing surgeons as was witnessed in the past. Existence of the wide variations in the different structures of the inguinal anatomy is now well recognized, thus adding to its complexity. Words of Jonathan Spitz and Maurice Arregui (2001) are prophetic that “As comprehensive knowledge of the preperitoneal fascial anatomy becomes more widespread, there likely will be a broader application of the laparoscopic preperitoneal hernia repair.”

4. Research Methodology The research methodology adopted in the present work is detailed in the Chapter II and is summarized in Fig.1. However, the various parameters for the patient’s selection, research technique and software tools used for the proposed study are described briefly as listed below:

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4.1. Selection Criteria for the Study 4.1.1. Patient’s choice under the informed consent 4.1.2. Patient’s good financial status: The existing financial circumstances of the patients including patients’ ability to expend extra money for the laparoscopic procedure (our institution charges double for the laparoscopic hernioplasty as compared to the open hernioplasty). 4.1.3. Pre-operative feasibility of laparoscopic hernioplasty based on the pre-anaesthetic check-up (PAC) in out-patient department (OPD) 4.1.4. Availability of functioning laparoscopic equipment and instruments 4.1.5. Availability of the expertise (laparoscopic surgeon) 4.2. Inclusion Criteria for the Study 4.2.1. Patients with age more than 18 years, 4.2.2. Patients with Uncomplicated Fully Reducible Primary Inguinal Hernia 4.2.3. Patients with ASA grade I – II only (American Society of Anesthesiologists) 4.2.4. Written Informed Consent for laparoscopic repair of inguinal hernia 4.3. Exclusion Criteria for the Study 4.3.1. Patient’s refusal for laparoscopic repair 4.3.2. Patients with age less than 18 years, 4.3.3. Patients with severe co-morbid disease (ASA grade III - V) 4.3.4. Patients with recurrent hernia 4.3.5. Patients with complicated hernia (Irreducible/Inflamed/Obstructed/ Strangulated) 4.3.6. Patients with femoral and other groin hernia 11

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4.3.7. Patients with history of lower abdominal surgery 4.4. Approval by Ethical and Scientific Committee of the University 4.5. Admission of Patients to the Hospital one Day Prior to Surgery 4.6. Patients’ Written Informed Consent 4.7. Surgical Technique The standard 3-midline-port technique of the total extraperitoneal preperitoneal (TEPP) hernioplasty as reported earlier (Ansari, 2013) was adopted, utilizing the direct telescopic dissection initially, followed by the blunt/sharp dissection with the Maryland dissector and scissors. After creation of adequate preperitoneal space between transversalis fascia and preperitoneal fascia and the parietalization of the cord structures, a requisite polypropylene mesh was placed, and then fixed with a single polypropylene suture to the pectineal ligament in majority of the cases. 4.8. Instant Data Collection and Documentation along with the video recording of the procedure as and when possible 4.9. Follow-up after discharge from the hospital: 1 wk, 4 wk, 3 mo, 6 mo and yearly 4.10.

Statistical Analysis – Statistical Package for Social Sciences (SPSS v.21)

5. Outcome Measures in the Present Study The outcome measures in the present study included the primary and secondary outcome measures as mentioned in the following paragraphs: 5.1. Primary Outcome Measures 5.1.1. Nature, layer & extent of Infra-umbilical Posterior Rectus Sheath 5.1.2. Nature, number and level of Arcuate Line 5.1.3. Nature, layer and extent of Infra-umbilical Transversalis Fascia

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5.1.4. Nature, layer and extent of Infra-umbilical Pre-Peritoneal Fascia 5.1.5. Nature, layer and extent of Infra-umbilical Pre-Peritoneal Fat 5.2. Secondary Outcome Measures 5.2.1. Intra-operative Functioning (Endoscopic vision, ease of the procedure and operation time) 5.2.2. Intra-operative Complications (Peritoneal injury, surgical emphysema and conversion) 5.2.3. Post-operative Complications (Seroma, infection, chronic groin pain and recurrence of hernia)

6. Observations and Results A total of 63 patients with the uncomplicated primary inguinal hernia (Unilateral 54 [Left side 36; Right side 18] and Bilateral 9) were taken up for the TEPP hernioplasty in a period for about five years w.e.f. February, 2011 to November, 2015. Three patients (one with left unilateral hernia, one with right unilateral hernia and one with bilateral hernia) were excluded due to an early conversion to TAPP (n=1) and open surgery (n=2), the three causes of conversion being: (1) immediate peritoneal injury on an attempt for the 1st port placement, (2) early injury to the deep inferior epigastric vessels by the roughened joint of the Maryland dissector just after placement of the 1st working port, and (3) severe CO2 retention with anaesthetic problem soon after the start of the procedure. Thus, 60 patients underwent TEPP hernioplasty successfully for 52 unilateral hernias (Left side 35; Right side 17) and 8 bilateral hernias, and the data analysis was carried for a total of 68 TEPP hernioplasties (Unilateral TEPP 52; Simultaneous Bilateral TEPP 5; Interval Bilateral TEPP 3) which formed the body of the present study. The results are herein presented in the format of mean ± standard deviation unless specified otherwise. In terms of the patients’ profile, all patients were male, with an overall mean age and BMI of 50.1±17.2 years (range 18-80) and. 22.6±2.0 kg/m2 (range 19.3-31.2) respectively. The ratio of ASA grades I and II was 4.5: 1. The patients varied across occupations in the following manner - manual labourers (N=24), retired persons (N=9), office workers (N=8), students (N=7), farmers (N=6) and field workers (6). Associated non-clinical hernias were observed during the operation in 3% of the cases. 13

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6.1. Primary outcome measures: 6.1.1. Posterior Rectus Sheath (PRS) The classically described posterior rectus sheath (PRS) was found in only 46% of the cases, while in the other 54%, the PRS was found variant types which included short whole tendinous (4.4%), long whole tendinous (4.4%), complete-length whole tendinous (8.8%), normal-length partly tendinous (11.8%), long partly tendinous (10.3%), normal-length thinned out (1.5%), complete-length thinned out (4.4%), normal-length grossly attenuated (1.5%), complete-length grossly attenuated (4.4%), complete-length

partly

tendinous

(1.5%),

and

complete-length

musculo-tendinous

(1.5%).

Additionally, the anatomy of the PRS was not a mirror image on the two sides of the body in 75% of the bilateral hernias. 6.1.2. Arcuate Line (AL) The classically taught arcuate line (AL) was seen only in 46% of the cases, and in the remaining 54%, the AL was of the 6 variant types which included the high single sharp well-defined (4.4%), low single sharp well-defined (4.4%), normal-sited single ill-defined (14.7%), low-sited single ill-defined (5.9%), double (4.4%), and absent (20.6%). The AL, when present, was found situated, in general, at the 1/3rd of the distance from the umbilicus to the pubic symphysis (U-PS). Additionally, non-mirror anatomy of the AL was observed on the two sides of the body in 62.5% of the bilateral hernias. 6.1.3. Transversalis Fascia (TF) In the suprainguinal region, the transversalis fascia (TF) was found as a well-defined single membranous layer associated with little/no fat in 72% of the cases and as a thin flimsy layer in the remaining 28%. However, in the inguinal region, the TF was of three types – single diaphanous layer (60%), single membranous layer associated with little/no fat (15%) and thin flimsy layer (25%). In both the supra-inguinal and inguinal regions, the AL had mirror anatomy on the right and left sides in all cases of the bilateral hernias. 6.1.4. Analogs of the Transversalis Fascia The observed analogs of the transversalis fascia included the iliopubic tract (well-defined 72%; illdefined 26.5%; absent 1.5%), pectineal fascia (well-defined 22%; ill-defined 78%), transversus aponeurotic arch (classical tendinous 16%; high tendinous 6%; low tendinous 9%; very low tendinous 19%; absent 50%), superior lateral fascial sling (well-defined 93%; ill-defined 7%), inferior lateral 14

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fascial sling (well-defined 93%; ill-defined 7%), and interfoveolar ligament (well-defined 93%; illdefined 7%). Additionally, a medial fascial extension running transversely from the deep ring towards the urinary bladder was observed in 19% of the cases. All transversalis fascial analogs except pectineal fascia and iliopubic tract had mirror anatomy on the two sides of the body in all cases. Pectineal fascia and iliopubic tract had non-mirror anatomy in 12.5% and 37.5% of cases respectively. 6.1.5. Preperitoneal Fascia (PPF) Preperitoneal fascia (PPF) was observed as a definite single membranous layer in 82% of the cases, and as a double membranous layer in the remaining 18%. The PPF anatomy was mirror image on the two sides of the body in all cases of bilateral hernias. Internal spermatic fascia was found as an extension analog of the preperitoneal fascia in all cases in the present study, with formation of a secondary internal inguinal ring at its beginning. 6.1.6. Preperitoneal Fat (EPF) Preperitoneal fat (EPF) in the present study was minimally fatty in 56%, moderately fatty in 33.8%, and excessively fatty in 10% of the cases. Cord lipoma was present in 16.2% of cases and was observed as an extension analog of the EPF in all cases. Presence of cord lipoma did not have any correlation with the amount of the preperitoneal fat. 6.1.7. Additional Observations Additionally, a well-defined fascial condensation of the epimysium on the undersurface of the rectus abdominis muscle was constantly present in all cases and was labeled as the ‘Rectusial fascia’ for the sake of further discussion. It was found as a well-developed diaphanous or membranous layer in 88% of the cases, and thin flimsy in the remaining 12%. The rectusial fascia had mirror anatomy on the two sides of the body in all cases of the bilateral hernias. Moreover, the ‘rectusial fascia’ always extended down underneath the pubic bones, forming the anterior boundary of the anatomical retropubic space, and this extension analog may be called the ‘retropubic fascia’ for an easy reference. 6.2. Secondary outcome measures 6.2.1. Endovision and Ease of Procedure (EOP) Secondary outcome measures of the endovision and ease of procedure (EOP) were 8.20±1.33 VAS (range 4.0-95) and 7.27± 2.05 VAS (range 4.0-95) respectively, and both of them were adversely 15

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affected in presence of the variant anatomy in majority of the primary outcome measures, namely, posterior rectus sheath (PRS), arcuate line (AL), transversalis fascia (TF), transversalis fascial analogs (except the TA Arch, transversus aponeurotic arch) and preperitoneal fascia (PPF). However, the secondary outcome measures were not affected either by the anatomic variations in the TA Arch, preperitoneal fat (EPF) and rectusial fascia (RF), or by the presence or absence of the cord lipoma. 6.2.2. Operation Time (OT) Average operation time (OT) for the unilateral TEPP hernioplasty was 1.9 hours and it was adversely affected only in the presence of the variant anatomy of the PRS, AL and PPF. 6.2.3. Conversion Although the overall incidence of conversion to Open/TAPP hernioplasty was 4% of all cases, but conversion secondary to the anatomic variation (of a high arcuate line) was seen in only 1.4% of all cases. 6.2.4. Peritoneal Injury Overall incidence of the peritoneal injury was 28%, and its occurrence was significantly more only in the presence of the variant arcuate lines. Overall incidence of the surgical emphysema was 16%, and its development was significantly more in presence of the variant anatomy of the TF in inguinal region and the PRS. Overall incidence of the postoperative seroma was 10%, and its development was not affected by variation in the anatomy of most of the primary outcome measures except for TA Arch in which a reverse phenomenon of higher incidence of the seroma was observed in presence of the classical tendinous arch as compared to its several variant forms. 6.2.5. Correlations among Secondary Outcome Measures Correlation between the endovision and the EOP was directly significant. Correlation between the endovision & the OT was inversely significant. The EOP had inversely significant correlation with the OT, the peritoneal injury and surgical emphysema. The OT was directly correlated with the peritoneal injury. Early peritoneal injury (PI) forcing conversion to TAPP (transabdominal preperitoneal hernioplasty) in one case (1.6%) was found due to the anatomic variation of a high arcuate line as confirmed on the transabdominal laparoscopy. Incidence of port site infection was 6.7% of the cases and it also did not 16

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correlate with any primary or secondary outcome measure. Chronic inguinal pain was observed in 1.5% following TEPP hernioplasty in the present study and did not correlate with any of the primary or secondary outcome measure. Furthermore, there was no recurrence of inguinal hernia after TEPP hernioplasty in the mean follow-up period of 33±17 months (range 5-61). In a nutshell, the preperitoneal anatomy of the infra-umbilical and inguinal regions observed during the total extraperitoneal preperitoneal (TEPP) approach for the laparoscopic repair (N=68) of the uncomplicated primary inguinal hernia in 60 male patients of ASA grade I & II showed wide variations in the all the fascial layers with significant impact on the intra-operative working as well as the postoperative clinical outcome, indicating the prime importance of their timely recognition and judicious surgical dissection of the complex fascial tissue planes of the groin because the ultimate responsibility lies with the surgeon. Incidence of the individual variant anatomy in the 4 major structures studied, namely, posterior rectus sheath, arcuate line, transversalis fascia and preperitoneal fat/fascia ranged from 18% to 54% of the cases, along with a high percentage of overlap. Individual anatomic variations in the transversalis fascial analogs and the rectusial fascia varied from 7% to 84% of the cases. Thus the overall incidence of the anatomic variations singly or in combination was found 76.5% with respect to the 4 structures of primary outcome measure only, and 100% with respect to all the structures observed in the present study, i.e., in other words, not a single patient showed all the so-called normal structures starting from the rectusial fascia/posterior rectus sheath to the preperitoneal fat inclusive of their analogs as traditionally described in the standard textbooks.

7. Discussion Our observations confirmed the finding of wide variations in morphology and symmetry of the posterior rectus sheath and its arcuate line as reported by a number of investigators (Anson et al, 1960; McVay, 1974; Monkhouse and Khalique, 1986, Rizk, 1991; Arregui, 1997; Spitz and Arregui, 2001; Cunningham et al, 2004; Loukas et al, 2008; Mwachaka et al, 2009 and 2010; Rosen et al, 2016). The present study supports the opinion that the arcuate line may not always represent the termination of the posterior rectus sheath (Moffat, 1989; Rizk, 1991; Spitz & Arregui, 2001). Present observations confirmed the presence of a uni-laminar fascia transversalis, and strongly support the declaration of Mirilas (2012) that the bilaminar concept of the transversalis fascia is outdated, setting aside all controversies and confusions. Transversalis fascial analogs, i.e., discrete thickenings or 17

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condensations occur in the transversalis fascia (TF) at several places (Skandalakis et al, 1983), especially at points of muscle insertion or at its attachment to other fascial/aponeurotic structures. Many of these transversalis fascial analogs were observed with wide anatomic variations in the present study also. Preperitoneal fascia was found as a constant anatomic entity in the present study, confirming the observations of Anson et al (1960), Lampe (1964), Fowler (1975), Redman (1996) and Arregui (1997). This layer remained largely unknown to the surgeons unfamiliar with the older literature (Amid and Hiatt, 2008). Our finding of the internal spermatic fascia as an extension analog of the preperitoneal fascia with a secondary internal inguinal ring confirmed the earlier observations of Tobin et al (1946), Fowler (1975 and 1978); Redman (1996), Mirilas et al (2008), Arregui (1997), Diarra et al (1997) and Folscher et al (2000). Our observation of the cord lipoma as an extension analog of the preperitoneal fat strongly supports the opinions of Tobin et al (1946), Nyhus et al (1991), Read and Schaefer (2000), Heller et al (2002), and Carilli et al (2004). Rectusial fascia and double-layer preperitoneal fascia are reported for the first in this study. The recent trend of application of the laparoscopic surgery to the inguinal hernioplasty has a positive effect on the accurate understanding of surgeons about groin anatomy (Gazayerli, 1992; Condon and Carilli, 1994), and has led surgeons to necessarily learn the regional anatomy from a new posterior perspective (Condon, 1996). As rightly pointed out by Condon (1996), many of the gross anatomic descriptions of the groin prior to the mid-19th century were largely accurate, but somehow failed to translate into the textbook teachings for the general good of the students and practicing surgeons, leading to the fixed erroneous preconceptions in their minds. Arregui (1997) is absolutely correct that these traditional anatomical preconceptions lead to a rather reluctant tedious tendency to believe our own live observations even under magnification with collective wisdom (the whole team is really seeing the same structures at the same time on the video monitors), or to believe our own visions but to keep on adhering to the old rather erroneous interpretations. This is truly exemplified by his own (Arregui) double interpretations of relationship between the Retzius’ and Bogros’ spaces in the same article, in an attempt to fit into the old concepts, setting aside his own true observations at that moment. We also faced a similar problem in the early phase of our study towards discard of the concept of the so-called posterior lamina of the transversalis fascia.

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Summary

However, Maurice E. Arregui (1997) must be credited for the elaborate documentation and description of the preperitoneal fascia in the first-and-last-of-its-kind laparoscopic research work, which helped the present author to navigate successfully through the complex inguinal space vested with the multiple fascial layers. The requisite preperitoneal space could be regularly created between the transversalis fascia and the preperitoneal fascia with ease and safety, and no conversion secondary to the so-called difficult dissection occurred in the present study. The present observations confirmed that the total extraperitoneal preperitoneal (TEPP) approach for inguinal hernioplasty with the unhurried telescopic dissection immensely enhances our accurate understanding of the abdomino-pelvic anatomy, and provides an excellent perspective and opportunity not available with any other technique including the TAPP (trans-abdominal preperitoneal hernioplasty), especially in relation to the variably attenuated multilaminar fascial layers often present in the plane of or underneath the posterior rectus sheath below the arcuate line (actual or supposedly) which are responsible for the variable descriptions of the groin anatomy in the literature (Arregui, 1997). Further increase in the anatomic knowledge beyond the gross anatomic dissections is still possible with newer laparoscopic approaches (Avisse et al, 2000) and has resulted in the evolution of the laparoscopic surgery at par with that of the open procedures (Mirilas, 2005). The surgical philosophy of James Rosser (1994) that the anatomical Keys of Success should be based on the philosophy of Keys of Recognition for offense utilized during the American football is highly recommended. James Rosser further emphasized that a high level of safety and operator confidence during laparoscopic hernioplasty can only be achieved through ‘a logical, point-by-point, sequential recognition of the strategic structures’. Rao et al (2009) emphasized that awareness of the anatomic variations in groin is of surgical importance during the inguinal hernioplasty. Multilaminar fascial structures are clearly seen during the preperitoneal laparoscopy as is also evident by the observations of the present study but their interpretations still differ greatly among the various contemporary investigators as was witnessed in the past. Existence of the wide variations in the different structures of the inguinal anatomy is now well recognized to add to its complexity. Words of Jonathan Spitz and Maurice Arregui (2001) are prophetic that “As comprehensive knowledge of the preperitoneal fascial anatomy becomes more widespread, there likely will be a broader application of the laparoscopic preperitoneal hernia repair.” The well-organized laparoscopic repair 19

M.M. Ansari


Summary

based on the flawless knowledge of the preperitoneal anatomy and its variations will alleviate the sufferings of the individual to make him/her again a productive member of the society at an affordable cost and satisfaction, and will help the humanity at large. Every hernia surgeon should give the patients the best possible treatment in the light of current scientific knowledge (Berger, 2016). In the light of the present and previous observations of the frequent anatomic variations, it is really worth and fitting to conclude our discussion with 3 comments of the noted scholars of the field: 1) the comment of James Rosser (1994) that the surgeon must be equipped with the “crisp, precise anatomical knowledge”, 2) the comment of Claude Avisse and colleagues (2000) that “anatomy is unique to each individual”, and 3) the comment of Faure and associates (2006) that “the requirement for a flawless knowledge of preperitoneal anatomy and its variations” is essential for performing the well-organized preperitoneal repair with ease and safety, in order to fully realize its proven efficacy, low failure rate and reduced post-operative pain, in addition to the early return to the routine activity and work.

8. Conclusions The preperitoneal anatomy of the infra-umbilical and inguinal regions showed wide variations in the all the fascial layers studied in the present work, with significant impact on the intra-operative working as well as the post-operative clinical outcomes, indicating the paramount importance of their timely recognition and judicious surgical dissection of the complex fascial tissue planes of the groin in order to perform the TEPP hernioplasty with ease, rapidity and safety for the lasting cure and greatest patient satisfaction. Incidence of the individual variant anatomy in the 4 major structures studied, namely, posterior rectus sheath, arcuate line, transversalis fascia and preperitoneal fat/fascia ranged from 18% to 54% of the cases, along with a high percentage of overlap. Individual anatomic variations in the transversalis fascial analogs and the rectusial fascia varied from 7% to 84% of the cases. Thus overall incidence of the anatomic variations singly or in combination was 76.5% with respect to the 4 structures of primary outcome measure only, and 100% with respect to all the structures studied in the present work. The present study not only clarified the confusion between the transversalis and preperitoneal fascias but also discovered the presence of a double-layer preperitoneal fascia and ‘rectusial fascia’ with the ‘retropubic fascia’ as its extension analog. The study also confirmed the internal spermatic fascia as an extension analog of the preperitoneal fascia, and the cord lipoma as an extension analog 20

M.M. Ansari


Summary

of the preperitoneal fascia. Thus, the present observations reaffirm that the preperitoneal laparoscopy with the unhurried telescopic dissection provides an excellent perspective and opportunity not available with any other technique including the TAPP (trans-abdominal preperitoneal hernioplasty), and immensely helps in our accurate understanding of the abdomino-pelvic anatomy as is also evident from our six publications regarding the interim results (list attached). Moreover, the present study helped us to establish the TEPP hernioplasty with minimal morbidity at our institution and instilled a high degree confidence in residents and peers. Outlook after the study is summarized in Fig. 2.

Figure 2: Outlook at a Glance

Furthermore, there is a tremendous scope for future research in the anatomic knowledge with the use of newer laparoscopic approaches. More laparoscopic studies in larger population sample may help in further stratification and easy understanding of the anatomic entities, and involvement of a dedicated anatomist may make our efforts easier to expunge the erroneous descriptions and interpretations from the literature. Utilization of pre-operative high definition ultrasonography, intra-operative high 21

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Summary

definition endovision, and modern energy sources like Harmonic scalpel/LigaSure for surgical dissection will prove a boon to enhance the precise knowledge of the preperitoneal anatomy among the practicing surgeons for the betterment of the quality patient care for the masses. Use of a virtual-reality digital learning and training programme for the surgical anatomy for the TEPP hernioplasty will be a worthy pursuit, strategic investment and rewarding exercise to materialize the fast-evolving concept of ‘Digital Surgical Skill Lab’ under a scientific anatomic model as the one proposed in the thesis. Scope for future research is summarized in Fig. 3.

Figure 3: Scope for Future Research

References 1. Amid PK, Hiatt JR. Surgical anatomy of the preperitoneal space. J Am Coll Surg 2008; 207(2): 295. 2. Annibali R, Camps J, Nagan RF, Quinn TH, Arregui ME, Fitzgibbons RJ. Anatomical considerations for laparoscopic inguinal herniorrhaphy. In: Arregui ME, Fitzgibbons RJ, Kathouda N, McKernan JB, Reich H (eds.) Principles of Laparoscopic Surgery: Basic and Advanced Techniques. Springer-Verlag, New York, 1995, pp 409-425. 22

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Summary

3. Anson BJ, McVay CB (eds.). Surgical Anatomy. WB Saunders, Philadelphia, 1971, p 490. 4. Anson BJ, Morgan EH, McVay CB. Surgical anatomy of the inguinal region based upon a study of 500 body halves. Surg Gynecol Obstet 1960; 111: 707–725. 5. Arregui ME, Castro C, Nagan RF. Anatomy of the peritoneum, preperitoneal fascia and posterior lamina of the transversalis fascia in the inguinal area. In: Arregui ME, Nagan RF (eds.) Inguinal Hernia: Advances or Controversies?. Radcliffe Medical Press, Oxford, 1994, pp 23-34. 6. Arregui ME. Surgical anatomy of the pre-peritoneal fasciae and posterior transversalis fasciae in the inguinal region. Hernia 1997; 1: 101-110. 7. Avisse, C; Delattre, JF; Flament, JB. The inguinofemoral area from a laparoscopic standpoint History, anatomy, and surgical applications. Surg Clin North Am 2000; 80(1): 35-48. 8. Bendavid R. The Shouldice Hospital Repair. In: Daniel B. Jones (ed.) Master Techniques in Surgery: Hernia. Chapter 7, Lippincott-Williams-Wilkins, Philadelphia, 2013, pp 71-86. 9. Berger D. Evidence-Based Hernia Treatment in Adults. Deutsches Ärzteblatt International | Dtsch Arztebl Int 2016; 113: 150–158. 10. Brick WG, Colborn TR, Gadacz TR, Skandalakis anatomic lessons for laparoscopic herniorrhaphy. Am Surg 1995; 61(2): 172-7.

JE.

Crucial

11. Carilli S, Alper A, Emre A: Inguinal cord lipomas. Hernia 2004; 8: 252-254. 12. Colborn GL, Skandalakis JE. Laparoscopic inguinal anatomy. Hernia 1998; 2: 179-191. 13. Condon RE, Cailli S. The biology Semin Laparosc Surg. 1994; 1(2): 75-85.

and

anatomy

of

inguinofemoral

hernia.

14. Condon RE. Reassessment of the groin anatomy during the evolution of preperitoneal hernia repair. Am J Surg 1996; 172: 5-8. 15. Cunningham SC, Rosson GD, Lee RH, Williams JZ, Lustman CA, Goldberg NH, Silverman RP. Localization of the arcuate line from surface anatomic landmarks: a cadaveric study. Ann Plast Surg 2004; 53(2): 129-131. 16. Diarra B, Stoppa R, Verhaeghe P, Mertl P. About prolongations of the urogenital fascia into the pelvis: An anatomic study and general remarks on the interparietal-peritoneal fasciae. Hernia 1997; 1: 191-196. 17. Faure JP, Doucet C, Rigourd PH, Richer JP, Scepi M. Anatomical pitfalls in the technique for total extra peritoneal laparoscopic repair for inguinal hernias. Surg Radiol Anat. 2006; 28(5): 486-93.

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18. Folscher DJ, Leroy J, Jamali FR, Marescaux J. Totally extrafascial endoscopic preperitoneal hernia repair: a merger of anatomy and surgery. The exact description to endoscopically dissect the spermatic fascia. Hernia 2000; 4: 223-227. 19. Fowler R. The applied surgical anatomy of the peritoneal fascia of the groin and the "secondary" internal inguinal ring. Aust N Z J Surg 1975; 45(1): 8-14. 20. Fowler R. Special comment: The peritoneal fascia. In: Nyhus LM, Condon RE (eds.) Hernia. 2nd Edition, JB Lippincott, Philadelphia, 1978, pp 64–67. 21. Gazayerli MM. Anatomic laparoscopic hernia repair of direct or indirect hernias using the transversalis fascia and iliopubic tract. Surg Laparosc Endosc 1992; 2: 49-52. 22. Heller CA, Marucci DD, Dunn T, Barr EM, Houang M, Dos Remedios C: Inguinal canal ‘lipoma’. Clin Anat 2002; 15: 280-285. 23. Lampe EW. Special comment: Experiences with preperitoneal hernioplasty. In: Lloyd M. Nyhus, Robert E. Condon (eds.) Hernia. 1st Edition, JB Lippincott, Philadelphia, I964, pp 295-301. 24. Lange JF, Rooijens PPGM, Koppert S, Kleinrensink GJ. The preperitoneal tissue dilemma in totally extraperitoneal (TEP) laparoscopic hernia repair. Surg Endosc 2002; 16: 927-930. 25. Li G, Qian Y, Bai H, et al. Intertransversalis fascia approach in urologic laparoscopic operations. Arch Surg 2012: 147(2): 159-167. 26. Liem MS, van Steensel CJ, Boelhouwer RU, Weidema WF, Clevers G J, Meijer WS, Vente JP, de Vries LS, van Vroonhoven TJ. The learning curve of totally extraperitoneal laparoscopic hernia repair. Am J Surg 1996; 171: 281-285. 27. Loukas M, Myers C, Shah R, Tubbs RS, Wartmann C, Apaydin N, Betancor J, Jordan R. Arcuate line of the rectus sheath: clinical approach. Anat Sci Int 2008; 83(3): 140-144. 28. McVay CB. The anatomic basis for inguinal and femoral hernioplasty. Surg Gynecol Obstet 1974; 139: 931-945. 29. Mirilas P, Mentessedou A, Skandalais JE. . Secondary internal inguinal ring and associated surgical planes: surgical anatomy, embryology, applications. J Am Coo Surg 2008; 206(3): 561-570. 30. Mirilas P, Colborn GL, McClusky-III DA, Skandalakis LJ, Skandalakis PN, Skandalakis JE. The history of anatomy and surgery of the preperitoneal space. Arch Surg 2005; 140: 90-94. 31. Mirilas P. Intertransversalis approach for laparoscopic urology: surgical anatomy concerns. Arch Surg 2012: 147(10): 980. 32. Moffat DB (ed.) Lecture Notes on Anatomy. Blackwell Scientific Publications, Oxford, 1987, pp 201-209. 24

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33. Monkhouse, WS, Khalique, A. Variations in the composition of the human rectus sheath: a study of the anterior abdominal wall. J Anat 1986; 145: 61-66. 34. Mwachaka P, Odula P, Awori K, Kaisha. Variations in the Pattern of Formation of the Abdominis Rectus Muscle Sheath among Kenyans. Int J Morphol 2009; 27(4): 1025-1029. 35. Mwachaka PM, Saidi HS, Odula PQ, Awori KO, Kaisha WO. Locating the arcuate line of Douglas: is it of surgical relevance. Clin Anat 2010; 23(1): 84-86. 36. Nobel W, Marks SC Jr, Kubik S. The anatomical basis for femoral nerve palsy following iliacus hematoma. Neurosurg 1980; 52: 533-540. 37. Nyhus LM, Bombeck CT, Klein MS. Hernias. In David C. Sabiston (ed.) Textbook of Surgery: The Biological Basis of Modern Surgical Practice, 14th Edition, WB Saunders, Philadelphia, 1991, pp 1134-1148. 38. Pierpont RZ, Grigoleit AW, Finegan MK. The transversalis fascia: a practical analysis of an enigma. Am Surg. 1969; 35(10):737-40. 39. Rao MKG, Ramana V, Vincent R. A rare case of occurrence of fleshy muscle fibers in the anterior wall of rectus sheath. Int J Anat Var 2009; 1: 31–32. 40. Read RC, Schaefer RF. Lipoma of the spermatic cord, fatty herniation, liposarcoma. Hernia 2000; 4(3): 149-154. 41. Redman JF. The secondary internal ring: Applications to the surgery of the inguinal canal. The Journal of Urology 1996; 155(1): 170-173. 42. Rizk NN. A new description of the anterior abdominal wall in man and mammals. J Anat 1980; 131(3): 373-385. 43. Rizk NN. The arcuate line of the rectus sheath–does it exist? J Anat 1991; 175: 1-6. 44. Rosen MJ, Petro CC, Stringer MD. Anterior Abdominal Wall. In: Susan Standring (ed.) Gray’s Anatomy: The Anatomical Basis of Clinical Practice, 41st Edition, Chapter 61, Elsevier, UK, 2016, pp 1069-1082. 45. Rosser J. The anatomical basis for laparoscopic hernia repair revisited. Surg Laparosc Endosc 1994; 4(1): 36-44. 46. Skandalakis, J.E., Gray, S.W., Rowe, Jr., J.S.: Hernias. In: Anatomical Complications in General Surgery, New York, McGraw-Hill, Inc., 1983, pp. 252-281. 47. Spitz JD, Arregui ME. Fascial anatomy of the inguinal region. In: Robert Bendavid, Jack Abrahamson, Maurice E. Arregui, Jean B. Flament, Edward H. Phillips (eds.) Abdominal Wall 25

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Hernias: Principles and Management, 1st Edition (Reprint), Chapter 8, Springer Science-Business Media, New York, 2001, pp. 86-91. 48. Tobin CE, Benjamin JA, Wells JC. Continuity of the fasciae lining the abdomen, pelvis and spermatic cord. Surg Gynecol Obstet 1946; 83(5): 575-96. 49. Wagner JP, Brunicardi FC, Amid PK, Chen DC. Inguinal Hernias. In: F. Charles Brunicardi, Dana K. Andersen, Timothy R. Billiar, David L. Dunn, John G. Hunter, Jeffery B. Mathews, Raphael E. Pollock (eds.) Schwartz’s Principles of Surgery, 10th Edition, Chapter 37, McGraw Hill, New York, 2015, pp 1495-1520.

List of Publications Related to the Interim Results of the Thesis 1. Ansari (2013): Ansari MM. Effective Rectus Sheath Canal: Does It Affect TEP Approach for Inguinal Mesh Hernioplasty. Journal of Experimental and Integrative Medicine (Turkey) 2013; 3(1): 73-76. (https://www.ejmanager.com/fulltextpdf.php?mno=26727 ) 2. Ansari (2014): Ansari MM. Complete posterior rectus sheath and total extra-peritoneal hernioplasty. Saudi Surgical Journal 2014; 2: 80-83. (http://www.saudisurgj.org/temp/SaudiSurgJ2380-3134908_084229.pdf ) 3. Ansari (2015a): Ansari MM. Arcuate Line Variations: Are they important for TEP surgeons? Kuwait Medical Journal 2015; 47: 313-316. (https://www.kma.org.kw/uploads/versions/LLRTURJRFBGALXOVXAWJKMYY.pdf ) 4. Ansari (2015c): Ansari MM. Pre-Peritoneal Fascia/Fat – Laparoscopic Anatomy during Total Extra Peritoneal Hernioplasty. International Journal of Sciences and Applied Research (IJSAR), 2015; 2(10): 01-05. (http://www.ijsar.in/Admin/pdf/188.pdf ) 5. Ansari (2015b): Ansari MM. Fascia Transversalis - A Study of Live Surgical Anatomy during Laparoscopic Total Extra-Peritoneal Hernioplasty. International Journal of Science and Research (IJSR) 2015; 4(8): 1788-1796. (http://www.ijsr.net/archive/v4i8/SUB157803.pdf ) 6. Ansari (2015d): Ansari MM. Cord Lipoma - An Analogue of Preperitoneal Fat: A Laparoscopic Study. International Journal of Science and Research 2015; 4(12): 2052-2055. (https://pdfs.semanticscholar.org/d3e1/6e1149b0157086ad2253a340e12c8d254271.pdf )

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